Received May 26, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| DTAP | DTAP (DAPTACEL) | SANOFI PASTEUR | UNK | 3CA25C1 | IM / LL |
administration of an expired DAPTACEL dose with no AE; Initial information received on 13-May-2026 regarding an unsolicited valid non-serious case received from a health care professional (HCP). This case involves a 2-year-old male patient who received an expired dose of Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no adverse event. The patient's past medical history, past drugs, vaccination(s), family history, and concomitant medications were not provided. Concomitant medication(s) included [Varicella zoster vaccine live (Oka/Merck) (VARIVAX), Hepatitis a vaccine inact (VAQTA)]. On 08-May-2026, the patient received expired 0.5 mL (once) dose of Diphtheria-15/Tetanus/5AC Pertussis Vaccine as Suspension for injection of standard strength (batch: 3CA25C1, expiry: 30-Apr-2026) via intramuscular route in Left thigh for immunization, with no reported adverse event [Expired product administered) (latency: same day]. Action taken: Not applicable. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Varivax; Vaqta